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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, redesign and development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Predetermined Change Control Plan
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • GP-028 AI Development
      • Specific procedures
        • T-TF-028-001 AI Description
        • T-TF-028-002 AI Development Plan
        • T-TF-028-003 Data Collection Instructions
        • T-TF-028-004 Data Annotation Instructions
        • T-TF-028-005 AI Development Report
        • T-TF-028-006 AI Release Report
        • T-TF-028-007 AI Retraining Report
        • T-TF-028-008 AI Reevaluation Report
        • T-TF-028-009 AI Design Checks
        • T-TF-028-010 AI V&V Checks
        • T-TF-028-011 AI Risk Assessment
    • GP-029 Software Delivery and Commissioning
    • GP-030 Cyber Security Management
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-026 Market-specific product requirements
    • GP-110 Esquema Nacional de Seguridad
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Pricing
  • Public tenders
  • Procedures
  • GP-028 AI Development
  • Specific procedures
  • T-TF-028-009 AI Design Checks

T-TF-028-009 AI Design Checks

Table of contents
  • Purpose
  • Instructions
  • Checklist
    • R-TF-028-001 AI Description
    • R-TF-028-002 AI Development Plan
    • R-TF-028-003 Data Collection Instructions
    • R-TF-028-004 Data Annotation Instructions
    • R-TF-028-011 AI Risk Matrix
  • Conclusion
  • Verification

Purpose​

This checklist is used to verify that the Design Phase of the AI development lifecycle has been completed in accordance with procedure GP-028 AI Development. It ensures that the AI Description, Development Plan, Data Collection Instructions, Data Annotation Instructions, and initial Risk Matrix are complete, coherent, and provide a sufficient basis for proceeding to the Development Phase.

Instructions​

The verifier must assess each item in the checklist. For each item, select "Yes," "No," or "N/A" and provide comments where necessary, especially for any "No" answers. All "No" items must be resolved before the Design Phase can be considered complete and approved.

Checklist​

R-TF-028-001 AI Description​

Check ItemYes/No/NAComments
1. Is the purpose of the algorithm package clearly defined?
2. Are all algorithms and their functions clearly described?
3. Are the performance endpoints explicitly stated for each algorithm?
4. Are the success criteria clearly defined for each performance endpoint?
5. Are the overall data specifications (scale, diversity, expert annotation) defined?
6. Are the input and output specifications for each algorithm defined?
7. Are cybersecurity, transparency, and integration aspects sufficiently described?

R-TF-028-002 AI Development Plan​

Check ItemYes/No/NAComments
1. Is the project team and their responsibilities clearly defined?
2. Is the development environment (hardware, software, tools) specified?
3. Does the Data Management Plan cover data collection, curation, partitioning, and test set sequestration?
4. Does the Training & Evaluation Plan cover model architecture, training methodology, and post-processing?
5. Does the Release Plan specify the deliverables for the software integration team?
6. Does the plan include a comprehensive AI Risk Management Plan?

R-TF-028-003 Data Collection Instructions​

Check ItemYes/No/NAComments
1. Are there clear instructions for each type of data collection required?
2. Are the target population, inclusion/exclusion criteria clearly defined?
3. Are ethical considerations (GDPR, consent, IRB/CEIm approval) adequately addressed?
4. Are the technical protocols for data acquisition, de-identification, and transfer clearly specified?
5. Are image quality requirements clearly defined?

R-TF-028-004 Data Annotation Instructions​

Check ItemYes/No/NAComments
1. Are annotation protocols clear and unambiguous for each annotation task?
2. Are the qualifications for annotators clearly specified?
3. Is the Quality Control process, including multi-annotator review and consensus mechanism, well-defined?
4. Are annotation guidelines complete and sufficient to ensure consistency?

R-TF-028-011 AI Risk Matrix​

Check ItemYes/No/NAComments
1. Have initial AI risks related to data management (e.g., data bias, inaccurate labels) been identified?
2. Have initial AI risks related to model training and evaluation (e.g., overfitting) been identified?
3. Has an initial assessment of severity and likelihood been performed for the identified risks?
4. Have initial risk mitigation measures been identified?

Conclusion​

State the overall outcome of the design check.

☐ Design Phase Approved: All checks have been successfully passed. The project is cleared to proceed to the Development Phase.

☐ Design Phase Not Approved: One or more checks have failed. The responsible team members must address the comments and resubmit the design documentation for verification.

Overall Comments:

Provide any summary comments or required actions here.

Verification​

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: JD-009
  • Reviewer: JD-009
  • Approver: JD-005
Previous
T-TF-028-008 AI Reevaluation Report
Next
T-TF-028-010 AI V&V Checks
  • Purpose
  • Instructions
  • Checklist
    • R-TF-028-001 AI Description
    • R-TF-028-002 AI Development Plan
    • R-TF-028-003 Data Collection Instructions
    • R-TF-028-004 Data Annotation Instructions
    • R-TF-028-011 AI Risk Matrix
  • Conclusion
  • Verification
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI Labs Group S.L.)